At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
Eculizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Single-Arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment-Naïve Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
In Brief
A Phase 3 clinical trial evaluating Eculizumab for Atypical Hemolytic Uremic. Completed, enrolled 25 participants across 6 sites.
Detailed Summary
This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) in China
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtypical Hemolytic Uremic
CountriesChina
CollaboratorsAstraZeneca
Timeline
Phase 3CompletedFinished
202420252026
First PostedMay 2023
Enrollment StartJul 2023
Primary CompletionMay 2025
TodayJul 2026
First PostedMay 25, 2023
Enrollment StartJul 14, 2023
Primary CompletionMay 7, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 3.1 years ago
Interventions
Eculizumabdrug
Weight-based doses of Eculizumab will be administered intravenously as an induction dose followed by maintenance dose at Day 8, 15, or 29 depending on weight; then every 2 or 3 weeks, depending upon weight.